Consensus guidelines on anti-cardiolipin antibody testing and reporting

Richard C W Wong, David Gillis, Stephen Adelstein, Karl Baumgart, Emmanuel J Favaloro, Michelle J Hendle, Paul Homes, Wendy Pollock, Stewart Smith, Richard H Steele, Allan Sturgess, Robert J Wilson

Research output: Contribution to journalArticlepeer-review

70 Citations (Scopus)


UNLABELLED: Consensus guidelines on anti-cardiolipin antibody (aCL) testing have been developed to help minimise laboratory variation in the performance and reporting of aCL assays. These guidelines include minimum, optimum and optional recommendations for the following aspects of aCL testing and reporting: (1) isotype of aCL tested; (2) specimen type; (3) controls and assay precision; (4) calibrators; (5) patient samples; (6) rheumatoid factors and IgM aCL testing; (7) reporting of results; (8) cut-off values; and (9) interpretative comments.

ABBREVIATIONS: aCL, anti-cardiolipin antibodies; APS, anti-phospholipid antibody syndrome; ASCIA, Australasian Society of Clinical Immunology and Allergy; ASTH, Australasian Society of Thrombosis and Haemostasis; beta2-GPI=beta2-glycoprotein I; ELISA, enzyme-linked immunosorbent assay; NCCLS, National Committee for Clinical Laboratory Standards; HSANZ, Haematology Society of Australia and New Zealand; QAP, Quality Assurance Program; RCPA, Royal College of Pathologists of Australasia; %CV, inter-assay inter-run coefficient of variation.

Original languageEnglish
Pages (from-to)63-8
Number of pages6
Issue number1
Publication statusPublished - Feb 2004


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